News & Knowledge Risk Management Guide: Medical Device and Drug Safety Recalls FDA uses the term "recall" when a manufacturer takes a corrective or removal action to address a problem with a medical device or drug that violates FDA regulations. Recalls occur when a medical device or drug is defective, when it could be a health risk, or when it is both defective and a health risk. Usually, the device or drug manufacturer recalls a device or drug independently. Accountability for medical device and drug safety recalls A person(s) should be appointed to lead all recall-related matters. This individual should subscribe to recall alerts and regularly monitor official channels, which can help healthcare organizations stay proactive in identifying and addressing recall issues. Monitor information on FDA recalls using… Are you a Curi member? The full content of this resource is available only to Curi members. Contact us if you are a member but do not have an account yet, or to learn more about becoming a Curi member. Sign in with Curi - or - Sign in with Constellation Curi’s risk mitigation resources and guidance are offered for educational and informational purposes only. This information is not medical or legal advice, does not replace independent professional judgment, does not constitute an endorsement of any kind, should not be deemed authoritative, and does not establish a standard of care in clinical settings or in courts of law. If you need legal advice, you should consult your independent/corporate counsel. We have found that using risk mitigation efforts can reduce malpractice risk; however, we do not make any guarantees that following these risk recommendations will prevent a complaint, claim, or suit from occurring, or mitigate the outcome(s) associated with any of them. READ NEXT July 22, 2024Clinical Care | Hospitals/Health Systems | Practice Management | Risk Management Resource Links A variety of comprehensive resource links on common areas of health care risk. Read more July 22, 2024Clinical Care | Hospitals/Health Systems | Risk Management Compounded Medications FAQs and Risk Mitigation Strategies DRUG COMPOUNDING FAQs What is drug compounding? According to the Food and Drug Administration (FDA), drug compounding is “the process of combining, mixing, or altering ingredients… Read more July 22, 2024July 22, 2024Clinical Care | Hospitals/Health Systems | Risk Management Mitigating Artificial Intelligence (AI) Risks in Healthcare Settings Artificial intelligence (AI) is machine-displayed intelligence that simulates human behavior or thinking and can be trained to solve specific problems using extensive data from past examples… Read more